Improving Medication Adherence in Geriatric T2DM Patients: A Factorial Randomized Controlled Trial

Abstract Background: The complexity of managing type 2 diabetes (T2D) in the elderly is compounded by the need to balance over-prescription, under-prescription, and appropriate prescription. Managing hyperglycemia and its complications, along with geriatric syndromes such as cognitive impairment and falls, often leads to use of an increased number of medications. Quality improvement measures, while aimed at better management, can inadvertently contribute to the burden of polypharmacy. Addressing medication non-adherence is crucial, as it is a significant contributor to poor clinical outcomes, increased hospitalizations, and healthcare costs. Objectives: This study thus aimed to evaluate the effectiveness of interventions to improve medication adherence among elderly patients with T2D. It assessed the impact of a medication adherence device, clinical pharmacological intervention, and their combination compared to standard of care (SOC) alone on adherence rates, adverse drug reactions (ADRs), and glycemic control. Materials and Methods: This pilot study was a factorial randomized controlled trial. A total of 120 elderly T2D patients with a medication adherence rate of less than 80% over the past year were randomized into four groups: (1) medication adherence device + SOC, (2) clinical pharmacological intervention + SOC, (3) combined intervention + SOC, and (4) SOC alone. The primary outcome was medication adherence, assessed through pill counting. ADRs were evaluated using the Naranjo ADR causality assessment scale, and glycemic control was monitored through HbA1c levels. Statistical analyses included chi-square tests and ANOVA, with significance set at P < 0.05. Results: Interim analysis showed the highest adherence rate in the combined intervention group (82.1%), followed by the clinical pharmacological intervention + SOC group (75.3%), the medication adherence device + SOC group (73.1%), and the SOC alone group (70.0%). The combined intervention group also recorded the lowest ADR rate (6.6%). Regarding glycemic control, 81% of the combined intervention group achieved an HbA1c level of less than 7%, compared to 80% in the clinical pharmacological intervention + SOC group, 78% in the medication adherence device + SOC group, and 69% in the SOC alone group. Differences in glycemic control were not statistically significant ( P = 0.950). Conclusions: The study indicates that combined interventions including medication adherence devices along with SOC significantly improve medication adherence and reduce ADRs in elderly T2D patients. Future research should focus on diverse populations and long-term sustainability of these interventions.